What is [18F]FAPI-74 PET/CT studying for gastric cancer?

This trial is studying how well a new scan called FAPI-PET/CT can detect spread of gastric cancer and if it can change treatment plans. It aims to see if this scan finds cancer spread more accurately and with less burden than current methods. The study is sponsored by Leiden University Medical Center.

Who may be eligible for this gastric cancer clinical trial?

Adults 18 years or older with confirmed adenocarcinoma of the stomach or esophagogastric junction (Siewert type III) that is considered operable may be eligible. Participants must be willing and able to undergo surgery and study procedures, and not be pregnant. Please review eligibility criteria for more details.

Is there any cost to participate in this gastric cancer clinical trial?

Study-related care, including the scan and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID07018661

18FF-FAPI PETCT and Laparoscopy in Staging Advanced Gastric Cancer - a Multicenter Prospective Study

Led by Leiden University Medical Center · Updated on 2025-08-27

250

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a new type of scan called FAPI-PETCT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PETCT scan, where a small amount of 18F-FAPI-74 is given intravenously about 60 minutes before a PETCT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.

CONDITIONS

Brief Title

[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed adenocarcinoma of the stomach or esophagogastric junction (Siewert type III) by gastroscopy
Age 18 years or older
Surgically resectable advanced tumor (cT3-4b, N0-3, M0) based on gastroscopy and contrast-enhanced CT of thorax and abdomen
Intention to perform gastrectomy based on multidisciplinary team decision
Written informed consent given
If recently in another drug study, no likely interaction with current study procedures as judged by study team

You will not qualify if you...

Siewert type I-II esophagogastric junction tumor
Unfit or unwilling to undergo study procedures
Unfit or unwilling to undergo surgery
Pregnancy at time of PET/CT scan due to radiation exposure
Incapacitated and unable to provide informed consent
Medical or psychiatric conditions preventing informed consent
Illiteracy preventing completion of questionnaires
Inability to undergo PET/CT scan due to claustrophobia, weight limits, or inability to lie flat for about 30 minutes

Research Team

Sarah Spruijt, M.D.

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